Evaluation of the safety and efficacy of new medicines is a crucial component of the drug development process, but one that has become increasingly complex and costly. Clinical trials today are often global, multi-site studies lasting sometimes for years in order to show improved efficacy over existing therapies or to demonstrate the safety of long-term treatments for chronic illnesses. In addition, many trials for rare and neglected diseases are now conducted in low-income countries with varying healthcare infrastructures and regulatory approval processes, which magnifies the challenges of limited enrollment, extended build and start-up times, lengthy and often fluctuating budget forecasts, and complex communication and collaboration between involved parties–demanding capabilities for meeting data capture, monitoring and reporting requirements.
“Cloud-based EDC software provides even more efficient data monitoring and reporting, enhanced communication and collaboration, and better budget forecasting”
A single late-stage clinical study can cost tens or even hundreds of millions of dollars, and the costs associated with trial monitoring can often account for as much as one-third to two-thirds of the total, according to a 2011 report by the Center for Global Development’s Working Group on Clinical Trials and Regulatory Pathways. In addition, a 2010 study by Adams and Brantner revealed that on average 90 percent or more of a drug’s development costs are incurred in Phase III trials. Such large, complex trials generate massive amounts of data that must be collected, monitored, controlled, analyzed and ideally shared with others in the healthcare industry. The streamlining of clinical studies thus requires efficient and effective management of reliable, robust and timely operational data.
The application of advanced technology solutions–particularly cloud-based Electronic Data Capture (EDC) systems–is essential for increasing efficiency and reducing cost. Such information technology platforms with advanced data management tools provide real-time visibility combined with the ability to process, analyze and evaluate the data and instantly share results with relevant stakeholders.
Electronic data capture has, in fact, been employed for clinical trial data management for many years. With the storage of protocols, assignments, and patient data in one central location for all sites in a clinical trial, cloud-based EDC software provides even more efficient data monitoring and reporting, enhanced communication and collaboration, and better budget forecasting. As a result, cloud-based EDC systems are ideally suited for more complex clinical trials studies being performed today.
With cloud-based EDC systems, data is entered from any study site around the world, and even from patient smartphones, into a central management system with built-in error management protocols and then collated in real time. Handling of thousands of paper Case Report Forms (CRFs) from multiple sites and data transfer into spreadsheets for further extensive analysis are eliminated, leading to significant increase in efficiency and reduction in errors and costs. More than 300 trial days were on average eliminated from trials that implemented EDC systems, according to one study reported by Thompson Reuters in 2011. Sertkaya et al. also estimated in 2014 that the use of EDC systems can reduce clinical trials costs by up to 24 percent.
In fact, the US Food and Drug Administration (FDA) encourages the use of EDC systems because they facilitate the monitoring and sharing of more accurate data between sponsors, investigators, patients and regulators, lead to increased compliance and lower the costs of clinical trials. In addition, because centralized data is accessible in cloud-based EDC systems in real time, it can be more rapidly organized and categorized for reporting purposes and as importantly searched on a continual basis to identify trends, patterns and significant outcomes much sooner than is possible, even with traditional EDC systems.
Consequently, advanced cloud-based EDC platforms enable the adoption of adaptive trial designs, which are also encouraged by FDA and have the potential to save sponsor companies $100 million to $200 million annually through early termination of unsuccessful studies, according to a 2013 report by the Tufts Center for the Study of Drug Development. The US House of Representatives has also expressed an interest in the benefits of EDC for accelerating drug discovery and development. Specifically, the 21st Century Cures Act (H.R. 6), which was passed by the House on July 10, 2015, includes several suggestions for streamlining clinical trials. Broader adoption of adaptive clinical trial designs aided by innovative technologies and statistical modeling is highlighted as an important first step.
FDA’s commitment to the adoption of advanced IT solutions was clearly enunciated by Leonard Sacks, then Acting Director for FDA’s Office of Critical Path Programs, in April 2012 at a workshop entitled “Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020”. He stated that “Harnessing information technology and novel scientific tools in the service of medical product development has been a central priority for FDA. These innovative tools provide a historic opportunity to move medical product development into the 21st century and to deal with the challenges of spiraling research and development costs in the face of diminishing returns.”
The implementation of EDC and other advanced data management technologies has the support of a number of other groups as well. As one example, the Center for Global Development’s Working Group on Clinical Trials and Regulatory Pathways recommends the use of EDC and centralized statistical sampling as a means for increasing the efficiency and productivity and lowering the costs of clinical trials focused on treatments for neglected diseases that are conducted in low-income countries.
It is also worth noting that cloud-based EDC platforms have the additional advantage over traditional EDC systems of enabling the avoidance of significant upfront and ongoing IT expenditures because the IT infrastructure and cloud-based software is owned and maintained by a third party. Some cloud-based EDC systems for clinical trial management also include forecasting and budgeting models and processes that can increase the efficiency and reduce the time required for the development and review of clinical trial budgets, which is a significant need in the industry.